Nextremity Solutions, Inc.

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Orthopedic Manual Surgical Instrument (LXH) (8) Staple, Fixation, Bone (JDR) (2)

Premarket Exempt

No Yes

Clear

Stealthfix Intraosseous Fixation System - 00810082896121 Catalog Number :

Device Description : StealthFix Inserter 4.5mm X 15mm

Device Class : 2

Duns Number: 060783407

Premarket Exempt : No

Product Code : JDR

Prescription Use : No

Device Count : 1

Stealthfix Intraosseous Fixation System - 00810082896138 Catalog Number :

Device Description : StealthFix Inserter 4.5mm X 20mm

Device Class : 2

Duns Number: 060783407

Premarket Exempt : No

Product Code : JDR

Prescription Use : No

Device Count : 1

Stealthfix Intraosseous Fixation System - 00810082896169 Catalog Number :

Device Description : StealthFix Saw Blade, Stryker 1mm X 43mm

Device Class : 1

Duns Number: 060783407

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

Stealthfix Intraosseous Fixation System - 00810082896213 Catalog Number :

Device Description : StealthFix Screw Depth Gauge

Device Class : 1

Duns Number: 060783407

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

Stealthfix Intraosseous Fixation System - 00810082896220 Catalog Number :

Device Description : StealthFix Joint Gauge 3.5mm

Device Class : 1

Duns Number: 060783407

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

Stealthfix Intraosseous Fixation System - 00810082896237 Catalog Number :

Device Description : StealthFix Joint Gauge 4.5mm

Device Class : 1

Duns Number: 060783407

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

Stealthfix Intraosseous Fixation System - 00810082896244 Catalog Number :

Device Description : StealthFix K-Wire Sleeve

Device Class : 1

Duns Number: 060783407

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

Stealthfix Intraosseous Fixation System - 00810082896251 Catalog Number :

Device Description : StealthFix Drill Sleeve

Device Class : 1

Duns Number: 060783407

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

Stealthfix Intraosseous Fixation System - 00810082896268 Catalog Number :

Device Description : StealthFix Screw Sleeve

Device Class : 1

Duns Number: 060783407

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

Stealthfix Intraosseous Fixation System - 00810082896282 Catalog Number :

Device Description : StealthFix Drill Guide 3.5mm X 15mm

Device Class : 1

Duns Number: 060783407

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

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